Implantable medical systems and methods including pulse generators and leads

Patent metadata

Field	Value
Publication number	US-10722704-B2
Application number	US-201815973219-A
Country	US
Kind code	B2
Filing date	May 7, 2018
Priority date	May 7, 2018
Publication date	Jul 28, 2020
Grant date	Jul 28, 2020

Abstract

Methods for implanting a puke generator (PG) within a pectoral region of a chest of a patient and devices having the PG. The PG has a housing that includes a PG electrode. Methods also include implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient. The first and second electrode segments are positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy.

First claim

What is claimed is:

1. A method comprising:
implanting a pulse generator (PG) within a pectoral region of a chest of a patient, the PG having a housing that includes a PG electrode; and
implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient, the first and second electrode segments being positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy, wherein implanting the second electrode segment includes making a tunnel that extends along an intercostal gap between a first access incision proximate to a xiphoid process and a second access incision that is positioned at or beyond a midaxillary line.

2. The method of claim 1 , wherein the first and second electrode segments are portions of a common lead coil that extends from a proximal end of the first electrode segment to a distal end of the second electrode segment, the common lead coil extending along the chest of the patient from the anterior of the chest toward the side of the patient, wherein the second electrode segment extends to or beyond a midaxillary line of the patient.

3. The method of claim 2 , wherein an active length of the common lead coil is at least 35 cm from the proximal end of the first electrode segment to the distal end of the second electrode segment.

4. The method of claim 1 , wherein the first and second electrode segments are spaced apart from one another, the second electrode segment being longer than the first electrode segment.

5. The method of claim 4 , wherein the second electrode segment has an active length measured between proximal and distal ends of the second electrode segment, the active length being at least 12 centimeters (cm), wherein the second electrode segment extends beyond a posterior axillary line.

6. The method of claim 1 , wherein implanting the at least one lead includes positioning one lead such that the one lead extends away from the pulse generator, extra-thoracically along a sternum, and along an intercostal gap so that a distal end of the one lead is positioned at or beyond a midaxillary line of the patient.

7. The method of claim 1 , wherein implanting the first electrode segment includes tunneling from a pocket where the pulse generator is positioned along a sternum of the patient to an intercostal gap at or below the apex of the heart.

8. The method of claim 1 , wherein implanting the pulse generator includes making a subcutaneous pocket and positioning the pulse generator within the subcutaneous pocket.

9. The method of claim 1 , wherein the first and second electrode segments are portions of a continuous elongated body that wraps about the patient, wherein implanting the first electrode segment and the second electrode segment includes making a xiphoid incision and an access incision at or beyond a midaxillary line near an intercostal gap.

10. The method of claim 1 , wherein the first electrode segment has an active length extending between a proximal end and a distal end of the first electrode segment, the active length being between 5 and 12 cm.

11. The method of claim 1 , wherein a defibrillation threshold (DFT) is at most 50 Joules and a volume of the pulse generator is at most 40 milliliters.

12. The method of claim 1 , wherein the first and second electrode segments are portions of a common lead coil that extends from a proximal end of the first electrode segment to a distal end of the second electrode segment, the common lead coil having an active length that is at least 35 cm from the proximal end of the first electrode segment to the distal end of the second electrode segment, the common lead coil extending along the chest of the patient from the anterior of the chest toward the side of the patient and extending to or beyond a midaxillary line of the patient, the pulse generator operable to generate a defibrillating energy of at most 50 Joules.

13. A method comprising:
implanting a pulse generator (PG) within a pectoral region of a chest of a patient, the PG having a housing that includes a PG electrode;
implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient, the first and second electrode segments being positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy; and
initiating the pulse generator and sensing cardiac activity, wherein the pulse generator is configured to analyze the cardiac activity and provide therapy in response to identifying a cardiac event-of-interest using the cardiac activity.

14. A subcutaneous implantable medical system comprising:
a pulse generator (PG) configured to be positioned subcutaneously within a pectoral region of a chest of a patient, the PG having a housing that includes a PG electrode, the PG having an electronics module; and
an elongated lead that is electrically coupled to the pulse generator, the elongated lead including a first electrode segment that is configured to be positioned along an anterior of the chest of the patient and a second electrode segment that is configured to be positioned along at least one of a posterior of the patient or a side of the patient, wherein an active length of the elongated lead extends between a proximal end of the first electrode segment and a distal end of the second electrode segment, the active length being at least 35 centimeters (cm), wherein the electronics module is configured to provide electrical shocks for antiarrhythmic therapy using the PG electrode and the first and second electrode segments.

15. The subcutaneous implantable medical system of claim 14 , wherein the first and second electrode segments are portions of a common lead coil that extends from the proximal end of the first electrode segment to the distal end of the second electrode segment, the common lead coil being sized to extend along the chest of the patient from the anterior of the chest to the posterior of the patient, an active length of the common lead coil being at least 35 cm from the proximal end of the first electrode segment to the distal end of the second electrode segment.

16. The subcutaneous implantable medical system of claim 14 , wherein the first and second electrode segments are spaced apart from one another, the second electrode segment being longer than the first electrode segment, the second electrode segment having an active length measured between proximal and distal ends of the second electrode segment, the active length being at least 12 cm, wherein the second electrode segment extends beyond a posterior axillary line.

17. The subcutaneous implantable medical system of claim 14 , wherein the first electrode segment has an active length measured between proximal and distal ends of the first electrode segment, the active length being between 5 and 12 cm.

18. The subcutaneous implantable medical system of claim 14 , wherein a defibrillation threshold (DFT) is at most 50 Joules and a volume of the PG is at most 40 milliliters.

Assignees

• Pacesetter Inc

Inventors

• Min Xiaoyi
• Fischer Avi
• Ryu Kyungmoo
• Mouchawar Gabriel A

Classifications

• A61N1/0504 Primary

  Subcutaneous electrodes · CPC title

• A61N1/0587 Primary

  Epicardial electrode systems; Endocardial electrodes piercing the pericardium · CPC title

• A61N1/3968

  Constructional arrangements, e.g. casings (A61N1/375 takes precedence) · CPC title

• A61N1/3956

  Implantable devices for applying electric shocks to the heart, e.g. for cardioversion · CPC title

• A61N1/3987

  characterised by the timing or triggering of the shock · CPC title